[Progress of clinical trials on breast cancer in China, 2011-2022].

内容摘要

Objective: To systematically summarize the research progress of clinical trials on breast cancer drugs in China from 2011 to 2022, as well as provide an overview of the marketed drugs. The goal is to offer data and decision-making evidence for relevant departments. Methods: Based on the registration database of the China National Medical Products Administration's Clinical Trial Registration and Information Disclosure Platform, as well as data from the domestic and imported drug query systems, an analysis was conducted on clinical trials of breast cancer drugs, including information on investigational drugs and marketed drugs from January 1, 2011, to December 31, 2022. The study compared differences between Chinese and foreign enterprises in terms of trial scope, trial phases, number of treatment lines, drug types, and mechanisms of action. Results: From 2011 to 2022, a total of 401 clinical trials for breast cancer were registered in China, accounting for 8.0% of the country's overall anti-tumor clinical trials (401/5 011), with 304 trials (75.8%) initiated by domestic enterprises. Over the past decade, clinical trials for breast cancer showed fluctuating growth, reaching a peak of 84 trials in 2020. These trials involved 254 drugs, with 156 (61.4%) being original drugs and 174 (68.5%) being targeted therapies. The most focused targets included human epidermal growth factor receptor 2 (HER-2), cyclin-dependent kinases 4/6 (CDK4/6), and estrogen receptors (ER). There are 50 drugs targeting HER-2 (28.7%), 35 targeting CDK4/6 (20.1%), and 31 targeting ER (17.8%). During the period from 2011 to 2022, a total of 15 drugs for treating breast cancer were approved and launched in China, covering 19 indications. Among these, 7 indications are for adjuvant or neoadjuvant therapy of early-stage breast cancer, and 12 indications are for advanced breast cancer. Conclusions: Substantial achievements have been made in the development of new breast cancer drugs in China from 2011 to 2022. However, there remains a significant gap in the innovation capabilities of domestic pharmaceutical companies compared to international counterparts in the field of breast cancer. Future efforts should be directed towards strengthening research and development in breast cancer, exploring new target points, and investigating combination therapy mechanisms. 目的： 系统分析2011—2022年中国乳腺癌药物临床试验的研究进展及上市药物概况，为相关部门提供数据及决策证据。 方法： 基于中国国家药品监督管理局药物临床试验登记与信息公示平台及国产药品及进口药品数据查询系统，分析2011年1月1日至2022年12月31日乳腺癌药物临床试验、试验用药品及上市药物信息，比较中国企业和国外企业在试验范围、试验分期、治疗线数及药物类型、作用机制等方面的差异。 结果： 2011—2022年，中国共注册登记401项乳腺癌药物临床试验，占中国抗肿瘤药物临床试验的8.0%（401/5 011），其中国内企业发起304项（75.8%）。近10年乳腺癌临床试验数量呈波动式增长，2020年达峰（84项）。上述试验共涉及254种药物，156种（61.4%）为原研药，174种（68.5%）为靶向药，其中，人表皮生长因子受体2（HER-2）、细胞周期蛋白依赖性激酶4/6（CDK4/6）、雌激素受体（ER）是乳腺癌临床试验更受关注的3个靶点，靶向HER-2的药物有50种（28.7%），靶向CDK4/6的35种（20.1%），靶向ER的31种（17.8%）。2011—2022年间共有15种治疗乳腺癌的药物在中国获批上市，涉及19种适应证，其中7个适应证针对早期乳腺癌的辅助或新辅助治疗，12个适应证为晚期乳腺癌。 结论： 中国乳腺癌新药研发在2011—2022年取得了巨大成果，但是国内药企在乳腺癌方面的新药创新能力较国际仍有较大差距，靶点分布有同质化趋向，建议国内企业挖掘中国乳腺癌人群特点，加大创新乳腺癌药物研发投入。.